HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Summary
The FDA issued a Class II for HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420- by Heartware, Inc.. Reason: Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responde.
Details
Source
Device Recall
External ID
Z-1105-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Lot/Code Info: GTIN 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872
Quantity Affected: 59 units
Reason for Recall
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Distribution
Finland and Turkey
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-30
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Heartware, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Heartware, Inc. have FDA actions?
Heartware, Inc. has 39 FDA actions in our database, including 39 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1105-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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